氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.221835381836191837001835811835571835990.04
214.201842861844171843520.06
单位质量响应值RSD%判断
12911.3212982.540.39数据可信
供试品溶液-24040801批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min182454-8245445.01545.236.8845.0245.236.89
279610-7961043.46343.46
386314-8631447.12347.12
483355-8335545.50745.51
574318-7431840.57440.57
691015-9101549.68949.69
5min1147125-14712580.32281.722.0280.3281.722.02
2146187-14618779.81079.81
3149388-14938881.55881.56
4154502-15450284.35084.35
5151506-15150682.71482.71
6149432-14943281.58281.58
10min1162211-16221188.55890.331.9888.5690.331.98
2165432-16543290.31790.32
3163091-16309189.03989.04
4170091-17009192.86092.86
5168681-16868192.09192.09
6163181-16318189.08889.09
15min1169709-16970992.65293.441.5092.6593.441.49
2170645-17064593.16393.16
3168310-16831091.88891.89
4174229-17422995.12095.12
5174383-17438395.20495.20
6169665-16966592.62892.63
20min1172651-17265194.25895.271.7294.2695.281.72
2175870-17587096.01596.02
3171086-17108693.40493.40
4177565-17756596.94196.94
5177940-17794097.14697.15
6171962-17196293.88293.88
30min1175684-17568495.91497.201.6795.9197.201.68
2180883-18088398.75298.75
3174305-17430595.16195.16
4180118-18011898.33598.33
5181020-18102098.82798.83
6176192-17619296.19196.19
45min1176771-17677196.50797.781.5596.5197.781.55
2181258-18125898.95798.96
3175588-17558895.86195.86
4180977-18097798.80498.80
5182354-18235499.55599.56
6177710-17771097.02097.02
60min1177314-17731496.80498.211.7896.8098.211.79
2183410-183410100.132100.13
3176212-17621296.20296.20
4181700-18170099.19899.20
5183087-18308799.95699.96
6177614-17761496.96896.97
90min1178533-17853397.46998.081.6197.4798.081.61
2181546-18154699.11499.11
3175432-17543295.77695.78
4181741-18174199.22199.22
5182978-18297899.89699.90
6177715-17771597.02397.02
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
氢溴酸伏硫西汀口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号D382/2305001对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.83对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数0.7867
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.221842781836371835081833231832291835950.23
214.201872931861981867460.42
单位质量响应值RSD%判断
12911.0413151.131.31数据可信
供试品溶液-24040802批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
2min116169-161698.77115.7924.808.7715.7924.80
235487-3548719.25019.25
326425-2642514.33514.33
434417-3441718.67018.67
533240-3324018.03118.03
628952-2895215.70515.71
5min1117655-11765563.82364.871.4763.8264.881.47
2122692-12269266.55666.56
3118994-11899464.55064.55
4120212-12021265.21065.21
5119474-11947464.81064.81
6118532-11853264.29964.30
10min1147031-14703179.75978.731.4079.7678.741.40
2143859-14385978.03878.04
3141797-14179776.91976.92
4146493-14649379.46779.47
5146620-14662079.53679.54
6145035-14503578.67678.68
15min1154956-15495684.05883.480.6384.0683.480.63
2155243-15524384.21384.21
3153061-15306183.03083.03
4153500-15350083.26883.27
5153485-15348583.26083.26
6153067-15306783.03383.03
20min1154989-15498984.07684.540.9084.0884.540.90
2157538-15753885.45885.46
3153608-15360883.32683.33
4156547-15654784.92184.92
5156625-15662584.96384.96
6155794-15579484.51284.51
30min1158851-15885186.17185.831.6486.1785.831.64
2159387-15938786.46186.46
3153111-15311183.05783.06
4160468-16046887.04887.05
5158959-15895986.22986.23
6158551-15855186.00886.01
45min1161920-16192087.83586.851.7387.8486.851.73
2161521-16152187.61987.62
3159561-15956186.55686.56
4162793-16279388.30988.31
5159729-15972986.64786.65
6155069-15506984.11984.12
60min1160243-16024386.92688.091.0786.9388.091.07
2164379-16437989.16989.17
3160433-16043387.02987.03
4163650-16365088.77488.77
5163324-16332488.59788.60
6162308-16230888.04688.05
90min1164905-16490589.45588.641.5489.4588.641.54
2162777-16277788.30088.30
3158690-15869086.08386.08
4165227-16522789.62989.63
5165245-16524589.63989.64
6163592-16359288.74288.74
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
120min1160115-16011586.85688.641.2286.8688.641.22
2165585-16558589.82489.82
3163215-16321588.53888.54
4162334-16233488.06088.06
5164968-16496889.48989.49
6164217-16421789.08189.08
极限1158701-15870186.08987.372.1086.0987.372.10
2165050-16505089.53389.53
3157141-15714185.24385.24
4158481-15848185.97085.97
5162577-16257788.19288.19
6164408-16440889.18589.19
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